Impact of Various Therapeutic Methods on Gait Quality, Physical and Mental Fitness of Postmenopausal Women.

NCT07304622 | Completed

• 1 other identifier: Kalisz 2025-09
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn which physical activity affects the quality of gait, physical and mental fitness of older women. The main questions it aims to answer are: Does any of the training methods improve the physical or mental fitness of postmenopausal women? Which of these training methods improves the physical and mental condition of postmenopausal women the most? Researchers will compare the results of three training groups to each other and to control group (with no training) to see which training method has the greatest impact on improving the quality of gait, physical fitness and mental health of postmenopausal women. Participants took part in physical activity classes that took place for 12 weeks, twice a week for 45 minutes. Before starting the first and after completing the last physical activity, participants participated in the following tests: resting circulatory parameters, anthropometric tests, respiratory spirometry, cardiorespiratory fitness assessment, Fullerton test, measurement of force distribution and foot pressure, physical activity level assessment (IPAQ), and questionnaires on health-related quality of life (SF-36), geriatric depression scale (GDS), and cognitive function assessment scale (MoCA).

Conditions

Physical Performance and Fitness in Old Age

Keywords

activity in geriatrics; postmenopausal mental fitness; body stability in old age; postmenopausal physical fitness; fullerton test; spirometry

Outcome Measures

Primary Outcomes (9)

• Level of Physical Fitness

  physical fitness measured using the Fullerton test

  From enrollment to the end of treatment/training at 14 weeks

• Quality of Life Assessment

  SF-36 Questionnaire * The recoded values for items within a domain are summed and then transformed to a 0-100 scale (0 = worst, 100 = best health). * Eight Scales (Domains): Physical Functioning (PF) Role Limitations due to Physical Health (RP) Role Limitations due to Emotional Problems (RE) Vitality (VT) Emotional Well-being (MH) Social Functioning (SF) Bodily Pain (BP) General Health (GH)

  From enrollment to the end of treatment/training at 14 weeks

• Assessment of Lung Function

  Vital Capacity in liters (L)

  From enrollment to the end of treatment/traing at 14 weeks

• Assessment of Lung Function

  Tidal Volume in millliliters (mL)

  From enrollment to the end of treatment/traing at 14 weeks

• Assessment of Lung Function

  Respiratory Rate (RR) in breath per minute (bpm)

  From enrollment to the end of treatment/traing at 14 weeks

• Assessment of Lung Function

  Tiffeneau-Pinelli Index - FEV1/FVC Ratio (%)

  From enrollment to the end of treatment/traing at 14 weeks

• Assessment of Lung Function

  Maximal Mid-Expiratory Flow Rate (MMEF or FEF 25-75) in L/s

  From enrollment to the end of treatment/traing at 14 weeks

• Level of Physical Fitness

  IPAQ international physical activity questionnaire (MET-minutes/week units) Measured various domains of the eve-ry-day life: at work, while traveling, doing housework or leisure activities and sports. It mea-sures the time spent sitting at weekdays and weekends. It allows easy classification of the respondents physical activity into three categories: low (below 600 MET-minutes/ week), moderate (600-1500 lub 600-3000 MET-minutes/week) and high (above 1500 or 3000 MET-minutes/week).

  From enrollment to the end of tratment/training at 14 weeks

• Quality of Life Assesment

  The Geriatric Depression Scale (GDS) * scoring involves answering yes/no questions, with points given for specific answers * For the common 30-item scale, scores usually mean: 0-9 Normal, 10-19 Mild Depression, 20-30 Severe Depression

  From enrollment to the end of treatment/training at 14 weeks

Secondary Outcomes (13)

• Anthropometric Measurements using TANITA MC-980 MA device (TANITA, Japan).

  From enrollment to the end of treatment/training at 14 weeks

• Assessment of Cognitive Function

  From enrollment to the end of treatment/training at 14 weeks

• FootMat Clinical 7.10 Measurement of Foot Load and its Behavior while Walking by pressure sensor mat, MobileMat, provide by Tekscan

  From enrollment to the end of treatment/training at 14 weeks

• Antropometric Measurements using TANITA MC-980 MA device (TANITA, Japan)

  from enrollment to the end of treatment/training at 14 weeks

• Anthropometric Measurements using TANITA MC-980 MA device (Tanita, Japan)

  from enrollment to the end of treatment/training at 14 weeks

Study Arms (4)

Coordination Group, the goal is to improve motor coordination and balance

ACTIVE COMPARATOR

Eye-hand coordination exercises, balance exercises, walking and running exercises, exercises with scarves and balls, senomotor exercises

Other: Coordination Training

Mobility Group, the goal is to improve the range of motion in the joints

ACTIVE COMPARATOR

Exercisec focused on the mobility of a single joint. The exercises performed in various positions and using small sports equipment. Yoga elements and breathing exercises were also included.

Other: Mobility Training

Core Stability Group, the goal is to improve postural stability

ACTIVE COMPARATOR

Exercises focused on the postural stabilization, exercises for steady positioning while sitting, standing, or moving. The exercises in various positions and using small sports equipment for the balance and core strength

Other: Core Training

Control Group not participating in any sports activity

NO INTERVENTION

The group included 25 women over 65 years of age. The group participated in no sports activities

Interventions

Core Training OTHER

The group included 25 women over 65 years of age. The group participated in sports activities twice a week for three months. Each training session lasted 45 minutes and focused on the postural stabilization to keep the body's center of mass within its, allowing for steady positioning while sitting, standing, or moving. The exercises were performed in various positions and using small sports equipment. exercises were chosen to improve the body's ability to control and maintain its position against gravity, enhancing balance and core strength

Core Stability Group, the goal is to improve postural stability

Mobility Training OTHER

The group included 25 women over 65 years of age. The group participated in sports activities twice a week for three months. Each training session lasted 45 minutes and focused on the mobility of a single joint. The exercises were performed in various positions and using small sports equipment. Yoga elements and breathing exercises were also included.

Mobility Group, the goal is to improve the range of motion in the joints

Coordination Training OTHER

The group included 25 women over 65 years of age. The group participated in sports activities twice a week for three months. Each training session lasted 45 minutes and focused on the coordination and balance. The exercises were performed in various positions and using small sports equipment to achieve smooth, accurate, and controlled movements. These was achieved by exercises with: * Coordination ladders - developing rhythm, speed, and precision * Unstable surface exercises - improving balance and postural control * Reaction exercises (e.g., responding to auditory/visual signals). * Multitasking tasks - combining physical and mental elements * Exercises in variable conditions (e.g., closed eyes, non-standard equipment). * Movement games and activities - varying directions, speeds, and reactions to external stimuli, developing the ability to switch and adapt movement.

Coordination Group, the goal is to improve motor coordination and balance

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• female
• minimum age 65 years
• independence in performing everyday activities
• ability to actively participate in sports activities twice a week
• consent from the doctor to participate in sports activities

You may not qualify if:

• diseases of the locomotor system preventing independement movement
• active or post cancerous disease
• unstable ischemic heart disease
• drug and alcohol addiction

Sponsors & Collaborators

• The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz: lead

Study Sites (1)

The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz

Kalisz, Wielkopolska, 62-800, Poland

Location

Study Officials

• Katarzyna Domaszewska, Prof.dr hab.

  University School of Physical Education in Poznan

  STUDY CHAIR

• Marta L Hofman, Master

  The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz

  PRINCIPAL INVESTIGATOR

• Piotr Szewczyk, Dr

  The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz

  STUDY DIRECTOR

• Katarzyna Sobczak, Dr

  University School of Physical Education in Poznan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 26, 2025
• Study Start: October 1, 2024
• Primary Completion: April 11, 2025
• Study Completion: April 30, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 1 year after publication with no end date
• Access Criteria: still on planning, beginning after the publication

Locations

PL (1)